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What's New With the FDA
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Vroomp
Posted 2/12/2019 7:48 AM (#762652)
Subject: What's New With the FDA



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Agency escalates enforcement action against local Walgreens, Circle K retail locations for repeatedly selling tobacco products to minors
The U.S. Food and Drug Administration today initiated enforcement action against certain retail locations of Walgreen Co. and Circle K Stores Inc. for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors. The agency filed complaints seeking No-Tobacco-Sale Orders (NTSO), which seek to bar the two specific retail locations from selling tobacco products for 30 days. The two retail outlets that are the subject of these NTSO actions are a Walgreens store in Miami, Florida, and a Circle K store in Charleston, South Carolina. Notably, Walgreens is currently the top violator among pharmacies that sell tobacco products, with 22 percent of the stores inspected having illegally sold tobacco products to minors. 

“I will be writing the corporate management of Walgreens and requesting a meeting with them to discuss whether there is a corporate-wide issue related to their stores’ non-compliance and put them on notice that FDA is considering additional enforcement avenues to address their record of violative tobacco sales to youth. We all share the important responsibility of keeping harmful and addictive tobacco products out of the hands of kids. Retailers in particular – especially those who position themselves as health-and-wellness-minded businesses – are on the frontlines of these efforts and must take that legal obligation seriously,” said FDA Commissioner Scott Gottlieb, M.D. 

When violations are found, the agency generally issues warning letters and may take enforcement actions, including civil money penalties and NTSOs. The NTSO action against this Walgreens outlet follows the issuance of more than 1,550 warning letters and 240 civil money penalty actions against Walgreens stores nationwide for unlawful tobacco product sales to minors. This is, however, the first NTSO action taken against a Walgreens store. While the NTSO action against Circle K is not its first, it marks the first time the agency has initiated an NTSO complaint for the sale of deemed products (cigars) to minors. Since 2010, FDA has issued over 1,045 warning letters and 205 civil money penalty actions to retailers doing business as Circle K for sales to minors.
 
AND
 
 
Release of 2018 Findings from the National Youth Tobacco Survey
On Feb. 11, results from the 2018 National Youth Tobacco Survey (NYTS) published in a an MMWR article, "Vital Signs: Tobacco Product Use Among Middle and High School Students – United States, 2011-2018 ." This article includes findings on current use of seven tobacco products, including cigarettes, cigars, e-cigarettes, smokeless tobacco, hookah, pipe tobacco, and bidi, as well as findings on use of multiple products and frequency of use. Below are some of the key findings:

Current Use of Tobacco Products in 2018
The study authors found that in 2018, approximately 5 million middle and high school students currently used any tobacco product, with over 3.6 million currently using e-cigarettes and about half (2.5 million) currently using a combustible tobacco product, such as cigarettes and cigars. For the fifth year in a row, e-cigarettes continued to be the most commonly used tobacco product among U.S. youth. Among current tobacco product users, 41.7 percent of high school students and 33.3 percent of middle school students used two or more tobacco products. E-cigarette and cigarette use was the most common combination among those using multiple products. 

Changes in Current Use Between 2017 and 2018 
From 2017 to 2018, use of any tobacco product increased significantly by 38.3 percent (19.6% to 27.1%) among high school students and by 28.6 percent (5.6% to 7.2%) among middle school students. Current e-cigarette use increased significantly by 77.8 percent (11.7% to 20.8%) among high school students and by 48.5 percent (3.3% to 4.9%) among middle school students between 2017 and 2018. Furthermore, frequent e-cigarette use (more than 20 days in the past 30 days), increased significantly by 38.5 percent (20.0% in 2017 to 27.7% in 2018) among high school students who were current e-cigarette users. 
Due to the alarming nature of these findings, they were released early in a Notes from the Field article in Nov. 2018. The current study finds that e-cigarettes were the primary driver of the increase in current use of any tobacco product among both middle and high school students. During this same period, although there were no significant changes in current use of combustible tobacco products, such as cigarettes and cigars, there was a slight uptick in any combustible tobacco product use (12.9% to 13.9%) and current cigarette use (7.6% to 8.1%) among high school students.

The high rates of youth tobacco use, particularly e-cigarette use, continue to be of concern to FDA. Last spring, FDA launched the Youth Tobacco Prevention Plan, which aims to prevent youth access to tobacco products; curb marketing of tobacco products aimed at youth; and educate teens about the dangers of using any tobacco product, including e-cigarettes, as well as educate retailers about their key role in protecting youth.  

As part of the plan, FDA has ramped up efforts around compliance of the marketing and sales of e-cigarettes and conducted an ongoing series of enforcement actions to prevent initiation of tobacco products, including e-cigarettes, by youth. FDA continues to invest in compelling, science-based campaigns to educate youth about the dangers of all tobacco products. In Sept. 2018, FDA launched the full-scale youth e-cigarette prevention effort under “The Real Cost” brand umbrella. In Nov. 2018, the concerning findings from the 2018 NYTS youth e-cigarette use data prompted FDA to outline a policy framework on actions to reduce youth e-cigarette use, targeting the central problems – youth appeal and access to flavored tobacco products. 

To learn more about FDA’s latest actions, and upcoming plans, read the FDA Commissioner’s statement on the release of the new findings. 
 
 So, once again premium cigars are lumped in with little cigars sold at Walgreens and Circle K..............
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gitfiddl
Posted 2/12/2019 10:06 AM (#762656 - in reply to #762652)
Subject: RE: What's New With the FDA



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Because we all can buy premium cigars at Walgreens.

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Cfickter
Posted 2/12/2019 10:29 AM (#762657 - in reply to #762652)
Subject: Re: What's New With the FDA



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This is typical scare tactics and government math. I am not saying that youth smoking is not a problem but the problem is not the product but the availability. I am all for more enforcement and no store should be exempt.
But you are lumping a small issue (cigars) into a larger all encompassing tobacco issue (e-cigs, cigarettes, smokeless, hookahs,pipe, etc...) Also the math doesn't add up, shocking for government work!, There are 33.4 million students 10-18 in middle to high schools in the US (US Census) so if there are 5 million users per the survey that is only 15%?
If there are 3.6 million e-cig and and other 2.5 million tobacco (I would assume 99% are cigarette and 1% are cigars) users (6.1 million, understanding some might use both as per noted) what does that really leave for the rest?
I would think Hookahs and smokeless are more prevalent than cigars
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Chefjohn
Posted 2/12/2019 10:33 AM (#762658 - in reply to #762657)
Subject: Re: What's New With the FDA



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Cfickter - 2/12/2019 11:29 AM

This is typical scare tactics and government math. I am not saying that youth smoking is not a problem but the problem is not the product but the availability. I am all for more enforcement and no store should be exempt.
But you are lumping a small issue (cigars) into a larger all encompassing tobacco issue (e-cigs, cigarettes, smokeless, hookahs,pipe, etc...) Also the math doesn't add up, shocking for government work!, There are 33.4 million students 10-18 in middle to high schools in the US (US Census) so if there are 5 million users per the survey that is only 15%?
If there are 3.6 million e-cig and and other 2.5 million tobacco (I would assume 99% are cigarette and 1% are cigars) users (6.1 million, understanding some might use both as per noted) what does that really leave for the rest?
I would think Hookahs and smokeless are more prevalent than cigars


Spot on Chuck
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ninfiction
Posted 2/12/2019 10:39 AM (#762659 - in reply to #762652)
Subject: Re: What's New With the FDA



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They need to stop calling Swisher Sweets and Black&Mild cigars, they are not cigars.
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Adwinistrator
Posted 2/12/2019 11:32 AM (#762661 - in reply to #762652)
Subject: Re: What's New With the FDA



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I agree with the concern on lumping these together.

On the other hand, Swisher owns Drew Estates, so it's not like they are completely separate markets...
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ninfiction
Posted 2/12/2019 2:53 PM (#762668 - in reply to #762661)
Subject: Re: What's New With the FDA



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Adwinistrator - 2/12/2019 11:32 AM

I agree with the concern on lumping these together.

On the other hand, Swisher owns Drew Estates, so it's not like they are completely separate markets...


Ever since the Swisher buy out DE and Swisher are the same in my mind and I avoid. I have a bunch pre buyout that I should burn and be done with it.

Yes, I'm salty, but there are plenty of other choices.
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Adwinistrator
Posted 2/12/2019 4:54 PM (#762671 - in reply to #762668)
Subject: Re: What's New With the FDA



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ninfiction - 2/12/2019 3:53 PM

Adwinistrator - 2/12/2019 11:32 AM

I agree with the concern on lumping these together.

On the other hand, Swisher owns Drew Estates, so it's not like they are completely separate markets...


Ever since the Swisher buy out DE and Swisher are the same in my mind and I avoid. I have a bunch pre buyout that I should burn and be done with it.

Yes, I'm salty, but there are plenty of other choices.


Kind of feelin the same.

Had half a box of t52 pigs come undone recently.

I might pick up Nica Rustica if the price is right, but that's about it
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klamm143
Posted 2/12/2019 8:43 PM (#762677 - in reply to #762661)
Subject: Re: What's New With the FDA



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Adwinistrator - 2/12/2019 12:32 PM I agree with the concern on lumping these together. On the other hand, Swisher owns Drew Estates, so it's not like they are completely separate markets...

 

Ditto........... 

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Cfickter
Posted 2/13/2019 6:45 AM (#762688 - in reply to #762661)
Subject: Re: What's New With the FDA



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Adwinistrator - 2/12/2019 12:32 PM I agree with the concern on lumping these together. On the other hand, Swisher owns Drew Estates, so it's not like they are completely separate markets...

 Yes, true.  But even the current legislation before the committee separates hand rolled from machine rolled.  that is how they plan on defining to divide the FDA oversight.
Still I wander how much of this is actually cigars.  I visit a lot of B&Ms and can honestly admit have not seen one minor purchase or attempt to purchase a premium cigar.  Now the local convenience store, maybe there.  My guess is that 99% of the multi use is e-cig and cigarettes 

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arrow34
Posted 2/13/2019 7:02 AM (#762689 - in reply to #762688)
Subject: Re: What's New With the FDA



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I would have to agree with you Cfickter. I think in some regions "cigar" smoking is a problem for underage 15-18, IE swishers or backwoods. Yeah they are not really cigars, but get lumped in and the sweet infusions or sugar coated tips make them appealing to kids. This new legislation can only help...
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Cfickter
Posted 2/13/2019 7:25 AM (#762693 - in reply to #762689)
Subject: Re: What's New With the FDA



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arrow34 - 2/13/2019 8:02 AM I would have to agree with you Cfickter. I think in some regions "cigar" smoking is a problem for underage 15-18, IE swishers or backwoods. Yeah they are not really cigars, but get lumped in and the sweet infusions or sugar coated tips make them appealing to kids. This new legislation can only help...

Interesting point Ed.  Just because this kind of data lumping can happen I looked at the actual questions in the survey.  Keep in mind this is a survey of about 18k kids that they will then extrapolate to the 50 some million students.

So I pulled the survey questionnaire and there are 5 specific question regarding cigars. The lead in text to these questions reads as follows: 
The next five questions are about the use of cigars, cigarillos, or little cigars such as Black and Mild, Swisher Sweets, Dutch Masters, White Owl, or Phillies Blunts.

As you can see all are focused on machine rolled convenience store level crap.  

The data around these questions leads me to believe most kids identify (or confuse) cigarillos with cigarettes

Question 20 reads - During the past 30 days, on the days that you smoked, about how many cigars, cigarillos, or little cigars did you smoke per day?

2 to 5 per day - 245 responded

6 to 10 per day - 61

11 to 20 per day - 29

More than 20 per day - 103 

 

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Cfickter
Posted 2/13/2019 9:22 AM (#762696 - in reply to #762652)
Subject: Re: What's New With the FDA



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When I wrote both of my US Senators about the bill now in front of the committee, I have had one response.

Dear Mr. Fickter:

Thank you for taking the time to contact me regarding S. 9, the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019. I appreciate hearing from you about this issue.

In 2009, passage of the Family Smoking Prevention and Tobacco Control Act, referred to as the "Tobacco Control Act," granted the Food and Drug Administration (FDA) the power to regulate tobacco products. In April 2010, the FDA announced its intention to regulate cigars under their new authority, and on April 25, 2014, the FDA issued a Notice of Proposed Rulemaking (NPRM) that outlined their intentions to regulate several products, including cigars. On May 5, 2016, the FDA completed this process by issuing a final rule that extends their regulatory oversight to these products. This final rule did extend FDA regulations to cigars, and did not provide an exemption for premium cigars.

Many individuals have expressed concerns about FDA regulation of premium cigars. They feel the Tobacco Control Act is primarily meant to regulate tobacco products that are frequently sought by children, and that FDA regulation of premium cigars will harm the premium cigar industry and substantially limit the ability of adult consumers to access a legal product.

In response to those concerns, Senator Marco Rubio of Florida has introduced S. 9, the Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2019. I support this legislation, which would clarify the Tobacco Control Act by exempting traditional large and premium cigars from the FDA's regulatory authority. This bill would allow the FDA to maintain their important authority over tobacco products that are more easily obtained by children, while protecting the rights of consumers to purchase a legal product. S. 9 was referred to the Committee on Health, Education, Labor, and Pensions, of which I am a member. Please be assured that I will continue to advocate for this important legislation.

While I understand the serious threat that tobacco products pose to the health of our Nation's youth and was a cosponsor of the Tobacco Control Act, premium cigars are not marketed to children, nor are premium cigars easily obtained by children due to their higher cost relative to products such as cigarettes. I remain open to reasonable proposals that might further balance the ability of adults to purchase a legal product with our need to fight underage consumption of tobacco products.

As always, I appreciate your views, thoughts and concerns as they assist me in understanding what is important to the people of Pennsylvania. Please do not hesitate to contact me in the future about this or any other matter of importance to you.

For more information on this or other issues, I encourage you to visit my website, http://casey.senate.gov. I hope you will find this online office a comprehensive resource to stay up-to-date on my work in Washington, request assistance from my office, or share with me your thoughts on the issues that matter most to you and to Pennsylvania.

Sincerely,
Bob Casey
United States Senator
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